Description and Brand Names

US Brand Name

Oncaspar

Descriptions

Pegaspargase belongs to the general group of medicines known as antineoplastics. It is used with other cancer medicines as a first-line treatment to a certain type of blood cancer called acute lymphoblastic leukemia (ALL). This medicine also treats ALL in patients who have had serious allergic reactions to L-asparaginase .

Pegaspargase seems to interfere with the growth of cancer cells, which are eventually destroyed. Since the growth of normal body cells also may be affected by pegaspargase, other effects also occur. Some of these effects may be serious and must be reported to your doctor.

Before you begin treatment with pegaspargase, you and your doctor should talk about the good this medicine will do as well as the risks of using it.

Pegaspargase is to be administered only by or under the immediate supervision of your doctor.

This medicine is available only with your doctor's prescription .

This product is available in the following dosage forms:

Solution

Before Using

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Infants up to 1 year of age—Safety and efficacy have not been established.

Children 1 year of age and older—This medicine has been studied in children 1 year of age and older and has not been shown to cause different side effects or problems than it does in adults. In fact, the side effects of this medicine seem to be less severe in children than in adults.

Geriatric

There is no specific information comparing the use of pegaspargase in the elderly with use in other age groups. Safety and efficacy of pegaspargase in the elderly have not been established.

Pregnancy

Information about this pegaspargase-intramuscular-route-intravenous-route

Pregnancy Category

Explanation

All Trimesters

C

Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

Breastfeeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Drug Interactions

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are receiving this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

Rotavirus Vaccine, Live

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

Adenovirus Vaccine Type 4, Live

Adenovirus Vaccine Type 7, Live

Bacillus of Calmette and Guerin Vaccine, Live

Influenza Virus Vaccine, Live

Measles Virus Vaccine, Live

Mumps Virus Vaccine, Live

Poliovirus Vaccine, Live

Rubella Virus Vaccine, Live

Smallpox Vaccine

Typhoid Vaccine

Varicella Virus Vaccine

Yellow Fever Vaccine

Other Interactions

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

Anticoagulant therapy (treatment with blood thinners) or

Bleeding problems—The chance of bleeding may be increased

Blood clots

Chickenpox (including recent exposure) or

Herpes zoster (shingles)—Risk of severe disease affecting other parts of the body

Liver disease—Effects of pegaspargase may be increased because of slower removal of this medicine from the body

Pancreatitis—The chance of side effects may be increased

Proper Use

Pegaspargase sometimes is given together with certain other medicines. If you are using a combination of medicines, it is important that you receive each one at the proper time. If you are taking some of these medicines by mouth, ask your doctor to help you plan a way to take them at the right times .

While you are receiving pegaspargase, your doctor may want you to drink extra fluids so that you will pass more urine. This will help prevent kidney problems and keep your kidneys working well.

This medicine often causes nausea and vomiting. However, it is very important that you continue to receive the medicine, even if you begin to feel ill. Ask your health care professional for ways to lessen these effects, especially if they are severe.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

Precautions

It is very important that your doctor check your progress at regular visits to make sure that this medicine is working properly and to check for unwanted effects.

While you are being treated with pegaspargase, and after you stop treatment with it, do not have any immunizations (vaccinations) without your doctor's approval. Pegaspargase may lower your body's resistance and there is a chance you might get the infection the immunization is meant to prevent. In addition, other persons living in your household should not take oral poliovirus vaccine, since there is a chance they could pass the poliovirus on to you. Also, avoid persons who have taken oral poliovirus vaccine. Do not get close to them, and do not stay in the same room with them for long. If you cannot take these precautions, you should consider wearing a protective face mask that covers the nose and the mouth.

Pegaspargase can temporarily lower the number of white blood cells in your blood, increasing the chance of getting infection. It can also lower the number of platelets, which are necessary for proper blood clotting. If this occurs, there are certain precautions you can take, especially when your blood count is low, to reduce the risk of infection or bleeding:

If you can, avoid people with infection. Check with your doctor immediately if you think you are getting an infection or if you get a fever or chills, cough or hoarseness, lower back or side pain, or have painful or difficult urination.

Check with your doctor immediately if you notice any unusual bleeding or bruising; black tarry stools; blood in urine or stools; or pinpoint red spots on your skin.

Be careful when using a regular toothbrush, dental floss, or toothpick. Your medical doctor, dentist, or nurse may recommend other ways to clean your teeth and gums. Check with your medical doctor before having any dental work done.

Do not touch your eyes or the inside of your nose unless you have just washed your hands and have not touched anything else in the meantime.

Be careful not to cut yourself when you are using sharp objects such as safety razor or fingernail or toenail cutters.

Avoid contact sports or other situations where bruising or injury can occur.

If pegaspargase accidentally seeps out of the vein into which it is injected, it may damage some tissue and cause scarring. Tell the doctor or nurse right away if you notice redness, pain, or swelling at the place of injection.

This medicine may cause serious allergic reaction. Tell your doctor immediately if you start having trouble breathing, chest tightness, skin rash, or itching while you are receiving this medicine .

Some people who have received this medicine developed pancreatitis (inflammation of the pancreas). Check with your doctor if you experience sudden and severe stomach pain, nausea, vomiting, fever, or chills while on this medicine .

Check with your doctor immediately if you start having increased thirst or hunger, increased urination, pale skin, nausea, sweating, or faintness. This may be signs that you are having problems with the amount of blood sugar in your body .

This medicine may increase your risk of developing serious blood clots. Tell your doctor right away if you develop any sudden and severe headache, arm or leg swelling, shortness of breath, or chest pain .

Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:

More common

Abdominal or stomach pain

blurry vision

constipation

dry mouth and skin

faintness

fatigue

fruit-like breath odor

increased hunger or thirst

increased need to urinate

nausea

skin paleness

skin rash

sweating

troubled breathing

unexplained weight loss

unusual bleeding or bruising

vomiting

Less common

Bloating

chest pain

confusion

cough

darkened urine

difficulty in breathing or swallowing

dizziness

fast heartbeat

fever or chills

headache

hives or itching

indigestion

itching, especially of hands and feet

loss of appetite

numbness, tingling, or swelling in arms or legs

pains in stomach, side, or abdomen, possibly radiating to the back

puffiness or swelling of the eyelids or around the eyes, face, lips or tongue

reddening of the skin, especially around ears

shortness of breath

swelling of eyes, face, or inside of nose

tightness in chest

unusual tiredness or weakness (sudden and severe)

wheezing

yellow eyes or skin

Rare

Black, tarry stools

blood in urine

hoarseness

lower back or side pain

painful or difficult urination

pinpoint red spots on skin

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

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